Neovacs Enrolls The First U.S. Patient In Phase IIb Study Of IFNa Kinoid For Treatment Of Systemic Lupus Erythematosus (SLE)

Strong interest from U.S. clinical investigation centers trial

PARIS and BOSTON, Nov. 07, 2016 (GLOBE NEWSWIRE) -- Neovacs (Alternext Paris:ALNEV) (PEA-eligible SMEs), a leader in active immunotherapy for the treatment of autoimmune diseases, today announced the enrolment of the first U.S. patient in its international phase IIb clinical study of IFNa Kinoid in lupus.

A first clinical center has started to enrol patients in this study, initially planned to include 5 investigation centers. The study has attracted interest from a large number of American sites and autoimmune disease specialists. Due to this high demand, Neovacs will open additional centers, increasing the total number of trial sites to 15.

This Phase IIb trial is part of a randomized, multicentric, international clinical study, initiated in September 2015. The ongoing study is evaluating IFNa Kinoid versus placebo in the treatment of systemic lupus erythematosus (SLE). Its objective is to assess the biological and clinical efficacy of IFNa Kinoid, the most advanced product in Neovacs' pipeline, in patients who have moderate to severe SLE. The trial is planned to include 178 patients in 21 countries in Latin America, Asia, Europe and USA.

Miguel Sieler, CEO of Neovacs declared: "The enthusiasm among U.S. investigators confirms the strong therapeutic interest in our product for the treatment of autoimmune diseases. Our lead drug candidate represents a potentially very interesting option for the treatment of lupus, an area where current therapeutic standards have failed to prove long-term efficacy. This is an area with a significant unmet medical need, and we look forward to continuing the study with the goal or providing a new therapeutic option for patients in need."

About Lupus

Systemic lupus erythematosus (SLE) or lupus erythematosus is a debilitating, chronic autoimmune disease whose etiology remains unknown. SLE is characterized by a loss of tolerance of self-antigens, with the production of autoantibodies, especially antinuclear antibodies that attack healthy tissues and cause inflammatory reactions in different parts of the body. The disease can affect multiple organs (skin, kidneys, joints, heart, lungs, central nervous system, etc. ) and is characterized by heterogeneous clinical signs (skin rashes, arthritis, photosensitivity, nephritis, neurological disorders, anemia, thrombocytopenia, etc.), which vary from one person to another and change during the progression of the disease. Systemic lupus erythematosus affects mostly women.